NCT06807593招募中2 期
Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events
研究概览
简要总结
The goal of this clinical research study is to learn if ustekinumab can help to control immune-related diarrhea and/or colitis in cancer patients.
详细描述
Primary Objectives:
To assess the efficacy of ustekinumab for clinical remission/response of immune-related diarrhea and/or colitis
To assess the efficacy of ustekinumab in reducing fecal calprotectin levels
Secondary Objectives:
To assess steroid free IMDC remission by week 4 and 8
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who receive any type of ICI therapy
- •Patients with ≥ grade 2 immune-related diarrhea and/or colitis according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 within 45 days prior to enrollment in study
- •Patients with ability to understand and willingness to sign informed consent
- •Patients with a diagnosis of any type of solid tumors on ICI systemic therapy
- •No concern for active concomitant GI infection for immune-related diarrhea and/or colitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation
- •Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T- spot due to BCG inoculation, chronic colonization) prior to initiation of diarrhea/colitis treatment and/ or imaging (e.g. CXR, CT CAP etc) confirms the absence of active infections (e.g. TB) within 60 days prior to initiation of protocol therapy
- •Concurrent or prior cancer therapy (non-checkpoint inhibitors) that are not deemed as a significant contributor of the GI adverse event can be allowed in the study.
- •Patients can be on the steroid treatment within 45 days before Ustekinumab
- •Patients with non- GI immune-related adverse events (irAEs) can be enrolled if there is no contraindication to the use of ustekinumab in the treatment of the non-GI irAEs present
- •Patients with a new index event of . grade 2 immune-related diarrhea and/or colitis may be enrolled if previous IMDC event was . 1 year ago with successful treatment and clinical remission
排除标准
- •Patients younger than 18 years of age
- •Patients with persistent gastrointestinal infection confirmed with positive testing despite completing 5 days of antibiotics
- •Patients with history of inflammatory bowel disease and/or radiation enterocolitis with active disease status at the time of study treatment initiation
- •Pregnant and breastfeeding women
- •Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was > 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to enrollment in study
- •Patients who develop concurrent non-GI toxicity (irAEs) at the time of study treatment initiation, with contraindication to the use of ustekinumab in the treatment of the non GI irAEs present
- •Patients have already received other biologic treatment for IMDC such as infliximab, vedolizumab, EXCEPT if these drugs were used in a previous IMDC event that occurred ≥ 1 year earlier at which time there was complete resolution of the disease
研究组 & 干预措施
Single Arm
Experimental
Participants will be identified per the evaluation of primary oncology and/or gastroenterology consult services.
干预措施: Ustekinumab (Drug)
结局指标
主要结局
Safety and Adverse Events
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点
研究者
研究点 (1)
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